Hydralazine Versus Labetalol for the Management of Hypertensive Disorders of Pregnancy

May 16, 2013 updated by: Osvaldo A. Reyes T., Saint Thomas Hospital, Panama

Hydralazine vs. Labetalol for the Management of Hypertensive Crisis in Patients With Hypertensive Disorders of Pregnancy. A Randomized Controlled Trial.

Hypertensive crisis (defined as a systolic pressure > 160mmHg or a diastolic pressure > 110mmHg) in patients with a hypertensive disorder of pregnancy is a serious complication with severe and even deadly consequences. The management in this population had been studied, but no consensus has been reached with regards to which treatment is better. Our study will compare two drugs: Hydralazine and Labetalol for the management of hypertensive crisis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

261

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Panama
      • Panama, Panama
        • Saint Thomas Maternity Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Gestational age > 24 weeks.
  • Hypertensive Crisis (systolic pressure > 160 mmHg / diastolic pressure < 110mmHg).

Exclusion Criteria:

  • Known allergy to hydralazine.
  • Known allergy to labetalol.
  • Severe Bradycardia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Hydralazine
Patients with an hypertensive crisis during pregnancy will receive 5mg IV every 15 minutes (Maximum number of doses: 3).
Drug: Hydralazine
Patients with an hypertensive crisis during pregnancy will receive 5mg IV every 15 minutes until high blood pressure is controlled (Maximum number of doses: 3).
ACTIVE_COMPARATOR: Labetalol
Patients with an hypertensive crisis during pregnancy will receive 20 mg of Labetalol IV. After 15 minutes if the crisis continue, 40 mg IV. After 15 minutes if the crisis continue, 80 mg IV. Then, if the crisis continue, 80 mg IV every 15 minutes (maximum dose: 300 mg IV in total).
Drug: Labetalol
Patients with an hypertensive crisis during pregnancy will receive 20 mg of Labetalol IV. After 15 minutes if the crisis continue, 40 mg IV. After 15 minutes if the crisis continue, 80 mg IV. Then, if the crisis continue, 80 mg IV every 15 minutes (maximum dose: 300 mg IV in total).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Control of Hypertensive Crisis
Time Frame: 10 months
Number of patients with hypertensive crisis in which the blood pressure is controlled with the use of the assigned drug, without requiring additional medications.
10 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse reactions
Time Frame: 10 months
Number of patients in each group that reported an adverse reaction to the drug assigned.
10 months
Number of doses
Time Frame: 10 months
Number of doses of the assigned drug required to lower blood pressure, without requiring additional medication.
10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saint Thomas Hospital, Panama

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (ACTUAL)

April 1, 2013

Study Completion (ACTUAL)

May 1, 2013

Study Registration Dates

First Submitted

February 18, 2012

First Submitted That Met QC Criteria

February 23, 2012

First Posted (ESTIMATE)

February 24, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

May 17, 2013

Last Update Submitted That Met QC Criteria

May 16, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MHST2012-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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